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Kindred Biosciences Announces Positive Results From Pivotal Study Of Kind-012 For Pyrexia In Horses, And Provides Other Product Updates

The following excerpt is from the company's SEC filing.

KIND-012 study meets primary endpoint with p<0.0001. Data to be filed with the FDA for approval. SentiKind study misses primary endpoint.

Conference call and webcast scheduled for 5:00 p.m. Eastern Time today.

Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced positive topline results from its pivotal field study (KB0120) of KIND-012 for the control of pyrexia (fever) in horses.

This study, KB0120, was a multicenter, randomized, blinded, placebo-controlled pivotal study that enrolled 138 horses to assess the effectiveness of KIND-012. The primary endpoint was improvement (a 2°F or greater decrease in temperature from baseline) or resolution of fever (a return to normothermia (≤101.0°F)) at hour 6 following treatment. The success rate was approximately 75% in the KIND-012 group vs. approximately 20% in the placebo group (p < 0.0001). Based on preliminary review of the safety data, the drug appears to be well tolerated.

KindredBio has already completed the in-life portion of the Target Animal Safety Study successfully and is currently preparing the Chemistry, Manufacturing, and Controls technical section of the New Animal Drug Application. The Company plans to file the Effectiveness Technical Section with the data from the KIND-012 pivotal field study with FDA in Q1 2016.

The Company also announced today that its pivotal field study (KB090) of SentiKind™ for the control of pain following orthopedic surgery in dogs did not meet its primary endpoint. The data are in the process of being fully analyzed to determine next steps for this program.

Richard Chin, M.D., President and Chief Executive Officer, stated, “We are very pleased and excited by the positive results of our pivotal KIND-012 study. KIND-012 addresses an important unmet medical need in horses and will be the first of what we believe will be multiple successful drug candidates in our equine franchise. We plan to file the data with the FDA expeditiously for approval of the drug and are excited about commercializing this product.”

“The SentiKind results, which we very recently unblinded, are obviously disappointing, especially for our canine patients, because better pain management choices are needed. We thank our investigators, pet owners, and team members who made this study possible. We believe in learning from our experiences, and we will apply the lessons we learned from our canine pain programs. For example, going forward, we plan to avoid, as much...


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